Surgical Sutures, Pgl, Gut, Deklene, Opthamend Etc

510(k) K930738

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

9 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK930738	Date26 Jul 1994Cleared	StatusActive

9 recalls · FDA

7 recalls, same reason
- Terminated Z-1555-2014 FDA Class II initiated 11 Mar 2014 on shared 510(k) K930738
- Terminated Z-1560-2014 FDA Class II initiated 11 Mar 2014 on shared 510(k) K930738
- Terminated Z-1558-2014 FDA Class II initiated 11 Mar 2014 on shared 510(k) K930738
- Terminated Z-1561-2014 FDA Class II initiated 11 Mar 2014 on shared 510(k) K930738
- Terminated Z-1557-2014 FDA Class II initiated 11 Mar 2014 on shared 510(k) K930738
- Terminated Z-1556-2014 FDA Class II initiated 11 Mar 2014 on shared 510(k) K930738
- Terminated Z-1559-2014 FDA Class II initiated 11 Mar 2014 on shared 510(k) K930738
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
- Terminated Z-1497-2014 FDA Class II initiated 11 Mar 2014 on shared 510(k) K930738
The products are being recalled because they did not meet minimum diameter requirements.
- Terminated Z-1018-2007 FDA Unclassified (pre-2012) initiated 6 Jun 2007 on shared 510(k) K930738
Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)